idursulfase 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
enzymes 4918 50936-59-9

Description:

MoleculeDescription

Synonyms:

  • idursulfase
  • iduronate-2-sulfatase
  • idursulfase (Genetical Recombination)
  • iduronate sulfatase
  • elaprase
  • EC 3.1.6.13
An enzyme that specifically cleaves the ester sulfate of iduronic acid. Its deficiency has been demonstrated in Hunter's syndrome, which is characterized by an excess of dermatan sulfate and heparan sulfate. EC 3.1.6.13.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Jan. 8, 2007 EMA Shire Human Genetic Therapies AB
July 24, 2006 FDA SHIRE

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infusion related reaction 503.35 36.35 236 7425 60570 42553104
Poor venous access 276.05 36.35 86 7575 7166 42606508
Inappropriate schedule of product administration 192.93 36.35 150 7511 95752 42517922
Product dose omission issue 176.47 36.35 175 7486 154190 42459484
Carpal tunnel syndrome 158.83 36.35 53 7608 5486 42608188
Pyrexia 156.65 36.35 264 7397 393778 42219896
Product availability issue 147.07 36.35 45 7616 3522 42610152
Seizure 86.02 36.35 107 7554 120454 42493220
Respiratory disorder 83.33 36.35 51 7610 22034 42591640
Patient uncooperative 82.37 36.35 20 7641 651 42613023
Respiratory distress 80.80 36.35 64 7597 41756 42571918
Hydrocephalus 80.63 36.35 33 7628 6045 42607629
Urticaria 78.90 36.35 81 7580 73955 42539719
Adenoidal disorder 78.30 36.35 14 7647 93 42613581
Respiratory tract infection 77.52 36.35 52 7609 26270 42587404
Ear infection 76.61 36.35 40 7621 12764 42600910
Adenoidal hypertrophy 76.32 36.35 15 7646 175 42613499
Catheter site swelling 74.21 36.35 18 7643 583 42613091
Rhinorrhoea 73.15 36.35 54 7607 31740 42581934
Illness 72.82 36.35 49 7612 24881 42588793
Inguinal hernia 71.55 36.35 34 7627 8878 42604796
Complication associated with device 71.04 36.35 31 7630 6650 42607024
Cough 67.12 36.35 117 7544 177986 42435688
Device related infection 66.86 36.35 43 7618 20236 42593438
Influenza 66.18 36.35 68 7593 62107 42551567
Tonsillar hypertrophy 61.85 36.35 17 7644 908 42612766
Drug ineffective 60.94 36.35 19 7642 630178 41983496
Infusion site extravasation 60.13 36.35 26 7635 5455 42608219
Cyanosis 60 36.35 36 7625 14995 42598679
COVID-19 57.02 36.35 86 7575 115862 42497812
Off label use 56.97 36.35 22 7639 638313 41975361
Vascular device infection 54.27 36.35 25 7636 6085 42607589
Umbilical hernia 53.80 36.35 24 7637 5423 42608251
Respiratory rate decreased 53.19 36.35 20 7641 2925 42610749
Body temperature increased 52.34 36.35 37 7624 20321 42593353
Otitis media 52.29 36.35 21 7640 3662 42610012
Central venous catheterisation 51.63 36.35 17 7644 1684 42611990
Acute kidney injury 51.07 36.35 4 7657 367333 42246341
Agitation 48.88 36.35 59 7602 64255 42549419
Device issue 47.90 36.35 30 7631 13479 42600195
Stridor 46.86 36.35 18 7643 2790 42610884
Nasopharyngitis 43.69 36.35 64 7597 83932 42529742
Gastrostomy 43.57 36.35 13 7648 932 42612742
Knee deformity 41.56 36.35 12 7649 767 42612907
Product distribution issue 41.38 36.35 15 7646 1979 42611695
Surgery 40.67 36.35 30 7631 17586 42596088
Bronchospasm 39.23 36.35 26 7635 12859 42600815
Poor quality sleep 38.68 36.35 23 7638 9417 42604257
Restlessness 38.58 36.35 36 7625 29213 42584461
Crying 38.30 36.35 20 7641 6374 42607300
Intellectual disability 38.15 36.35 14 7647 1913 42611761
Insurance issue 37.04 36.35 17 7644 4099 42609575
Discouragement 36.87 36.35 10 7651 508 42613166

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infusion related reaction 269.67 34.44 204 6364 380958 110201773
Poor venous access 242.41 34.44 80 6488 24442 110558289
Inappropriate schedule of product administration 194.28 34.44 131 6437 203506 110379225
Product dose omission issue 185.76 34.44 153 6415 321629 110261102
Pyrexia 166.34 34.44 233 6335 898032 109684699
Product availability issue 138.46 34.44 40 6528 7850 110574881
Carpal tunnel syndrome 125.18 34.44 48 6520 22562 110560169
Seizure 98.73 34.44 91 6477 221094 110361637
Respiratory distress 97.46 34.44 57 6511 68817 110513914
Patient uncooperative 85.67 34.44 18 6550 942 110581789
Inguinal hernia 79.48 34.44 26 6542 7699 110575032
Adenoidal hypertrophy 75.96 34.44 13 6555 221 110582510
Hydrocephalus 75.73 34.44 27 6541 10348 110572383
COVID-19 72.93 34.44 81 6487 244979 110337752
Respiratory disorder 70.45 34.44 47 6521 71335 110511396
Device related infection 70.25 34.44 38 6530 39481 110543250
Adenoidal disorder 69.16 34.44 12 6556 222 110582509
Respiratory tract infection 65.53 34.44 45 6523 71572 110511159
Catheter site swelling 64.99 34.44 17 6551 2307 110580424
Rhinorrhoea 63.57 34.44 51 6517 102615 110480116
Cyanosis 62.53 34.44 32 6536 29709 110553022
Cough 59.85 34.44 102 6466 461539 110121192
Influenza 59.29 34.44 61 6507 169040 110413691
Infusion site extravasation 58.35 34.44 23 6545 11611 110571120
Respiratory rate decreased 56.15 34.44 19 6549 6239 110576492
Complication associated with device 55.38 34.44 26 6542 20047 110562684
Umbilical hernia 54.00 34.44 19 6549 7003 110575728
Body temperature increased 53.91 34.44 36 6532 54677 110528054
Tonsillar hypertrophy 53.34 34.44 14 6554 1924 110580807
Agitation 53.26 34.44 48 6520 113003 110469728
Restlessness 53.00 34.44 36 6532 56223 110526508
Illness 51.24 34.44 41 6527 82130 110500601
Drug ineffective 50.66 34.44 14 6554 1520526 109062205
Device issue 49.93 34.44 29 6539 34506 110548225
Intellectual disability 48.31 34.44 13 6555 1966 110580765
Central venous catheterisation 48.03 34.44 15 6553 3827 110578904
Vascular device infection 47.45 34.44 22 6546 16490 110566241
Ear infection 47.20 34.44 35 6533 62697 110520034
Stridor 43.08 34.44 16 6552 6879 110575852
Off label use 41.12 34.44 19 6549 1500166 109082565
Viral infection 40.77 34.44 30 6538 53109 110529622
Bronchospasm 40.05 34.44 24 6544 30215 110552516
Urticaria 39.35 34.44 69 6499 318788 110263943
Otitis media 38.26 34.44 15 6553 7461 110575270
Gastrostomy 36.98 34.44 10 6558 1540 110581191
Knee deformity 36.90 34.44 10 6558 1553 110581178

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB09 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0000794 alpha-Glucosidases
FDA EPC N0000175823 Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Related Drugs by ATC class:

A16AB Enzymes 24 drugs
agalsidase alfaagalsidase betaalglucerasealglucosidase alfaasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfagalsulfaseidursulfase beta show all 24 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Mucopolysaccharidosis, MPS-II indication 70737009 DOID:12799




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
5W8JGG2651 UNII
D04499 KEGG_DRUG
4025595 VUID
N0000179797 NUI
4025595 VANDF
C1739462 UMLSCUI
CHEBI:749602 CHEBI
CHEMBL1201826 ChEMBL_ID
DB01271 DRUGBANK_ID
8222 INN_ID
C517982 MESH_SUPPLEMENTAL_RECORD_UI
644101 RXNORM
21811 MMSL
84277 MMSL
d05855 MMSL
011684 NDDF
424323009 SNOMEDCT_US
84524005 SNOMEDCT_US
D007066 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ELAPRASE HUMAN PRESCRIPTION DRUG LABEL 1 54092-700 SOLUTION, CONCENTRATE 6 mg INTRAVENOUS BLA 25 sections